510(k) · Cleared

Cleared

Modofocation to Synthes Ankle Arthrodesis Plates

K022255510(k) SpecialCleared Jul 25, 200213-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on Jul 25, 2002 as substantially equivalent to K013415 (Synthes (Usa), 2002) after a 13-day review. Its family tree reaches back 1 generation to 2002. 77 later devices descend from it.

Decided: Jul 25, 2002
Review: 13 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K013415 (2002). 77 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK013415 Synthes Ankle Arthrodesis PlateSynthes (Usa) · 2002
This deviceK022255 Modofocation to Synthes Ankle Arthrodesis PlatesSynthes (Usa) · 2002
Descendant · cites it directly · 76 of its ownK060473 TTC PlateNew Deal, S.A. · 2006
Descendant · cites it directly · 73 of its ownK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
Descendant · cites it directly · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
Descendant · 2 generations on · 56 of its ownK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010
Descendant · 2 generations on · 54 of its ownK090139 Ankle Arthrodesis Plate SystemTornier, Inc. · 2009

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

2006high 10 (2021) · low 1 (2006)2026

Most influential descendants

Showing 5 of 77 · See all

K060473TTC PlateNew Deal, S.A. · 2006 · cites it directly76descendants
K073375Newdeal Tibiaxys SystemNewdeal Sas · 2008 · cites it directly73descendants
K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · cites it directly69descendants
K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010 · 2 generations on56descendants
K090139Ankle Arthrodesis Plate SystemTornier, Inc. · 2009 · 2 generations on54descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K013415	Synthes Ankle Arthrodesis Plate	Synthes (Usa)	2002	—
0 (this device)	K022255	Modofocation to Synthes Ankle Arthrodesis Plates	Synthes (Usa)	2002	—
+1	K060473	TTC Plate	New Deal, S.A.	2006	—
+1	K073375	Newdeal Tibiaxys System	Newdeal Sas	2008	2
+1	K110670	VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone…	Smith & Nephew, Inc.	2011	—
+2	K100176	Ascension Ankle Fusion Plate System	Ascension Orthopedics, Inc.	2010	—
+2	K090139	Ankle Arthrodesis Plate System	Tornier, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2011	1	0
2012	2	0
2013	1	0
2014	4	0
2015	1	0
2016	1	0
2017	7	0
2018	3	0
2019	5	0
2020	7	0
2021	10	0
2022	2	0
2023	10	0
2024	6	0
2025	4	0
2026	8	0

FIG. 1 — Lineage of K022255, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K013415	Synthes Ankle Arthrodesis Plate	Synthes (Usa)	2002	—

What descends from it? (77)

See all 77

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060473	TTC Plate	New Deal, S.A.	2006	76
K073375	Newdeal Tibiaxys System	Newdeal Sas	2008	73
K110670	VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…	Smith & Nephew, Inc.	2011	69
K173121	Ankle Fusion Plating System	In2bones Sas	2017	2

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K060473 (New Deal, S.A., 2006) has gone furthest, with 76 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

The Synthes Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022255 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022255: Modofocation to Synthes Ankle Arthrodesis Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022255

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026